Leniolisib is a Pharming Group N.V. program in Activated PI3K-delta syndrome (APDS) in children (resubmission covering patients weighing 27 kg or more). Its next catalyst is a Readout in Nov 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Leniolisib is marketed as Joenja (leniolisib); the events below include those tracked under the brand name. Indication under review: Activated PI3K-delta syndrome (APDS) in children (resubmission covering patients weighing 27 kg or more). Sponsor: Pharming Group N.V. (PHAR). Review status: The FDA approved Joenja (leniolisib) for children with APDS on September 11, 2026, 43 days before the October 24 goal date Pharming had stated. The application was a resubmission adding data the FDA had requested on analytical methods for production batch testing, and covers paediatric patients weighing 27 kg or more; Pharming has said a separate sNDA for lower doses in patients under 27 kg is planned. Market-cap tier at the time we tracked it: Small. We track 3 catalyst events for this program: 1 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
The next tracked catalyst for Leniolisib is a Readout in Nov 2026.
On Sep 11, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Leniolisib is under review or in development for Activated PI3K-delta syndrome (APDS) in children (resubmission covering patients weighing 27 kg or more).
Pharming Group N.V. (PHAR).
Yes. The FDA approved an application for Leniolisib on Sep 11, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.